NCT01391689

Brief Summary

This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and be an effective treatment for breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
Last Updated

November 6, 2017

Status Verified

April 1, 2016

Enrollment Period

3.6 years

First QC Date

July 6, 2011

Last Update Submit

October 31, 2017

Conditions

Stage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Urinary 2OHE1:16alpha OHE1 ratio

    estrogen metabolites measured in ng/100ul; this outcome will also be reported as a ratio

    Up to 18 months

Secondary Outcomes (4)

  • Plasma TAM metabolites (ng/mL)

    Up to 18 months

  • Serum Estrogen (estradiol) (pg/mL)

    Up to 18 months

  • Self reported vaginal bleeding

    Up to 24 months

  • mammographic density

    up to 18 months

Study Arms (2)

Arm I (antineoplastic therapy)

EXPERIMENTAL

Patients receive diindolylmethane (BioResponse) PO BID for approximately 18 months.

Dietary Supplement: diindolylmethane

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID for approximately 18 months.

Dietary Supplement: placebo

Interventions

diindolylmethaneDIETARY_SUPPLEMENT

Given PO

Also known as: DIM
Arm I (antineoplastic therapy)
placeboDIETARY_SUPPLEMENT

Given PO

Also known as: PLCB
Arm II (placebo)

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prescribed TAM as adjuvant therapy for early stage (0, I, II, IIIa) breast cancer or as chemoprevention in women at high risk for breast cancer
  • New or planned prescription of TAM therapy; ineligible for randomization until on TAM for \> 3 months with the expectation to continue use for \> 18 months
  • Mammogram with Breast Imaging Reporting and Data System (BIRADS) score of \>= 2; (equivalent to the following and similar breast density descriptive terms found in mammogram reports: 2 = scattered fibroglandular elements/densities; 3 = heterogeneously dense tissue; 4 = extremely dense tissue)
  • No use of soy-based dietary supplements or willingness to discontinue use, complete a 4-week wash-out period, prior to randomization, and refrain from use during trial period
  • If pre-menopausal, non-pregnant (confirmed with urinary pregnancy test); practicing birth control or s/p oophorectomy
  • Able to complete study run-in activities, including taking study-provided placebo pill twice daily (AM \& PM) and recording pill intake and any symptoms experienced on a study calendar, with a compliance rate of at least 80%
  • Normal blood chemistry test that includes sodium and specific kidney and liver function tests (creatinine, alanine amino transferase-ALT, aspartate amino transferase-AST) within 30 days of study enrollment; (Informed Consent Form signed)
  • No history of hyponatremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85012, United States

Location

Related Publications (1)

  • Thomson CA, Chow HHS, Wertheim BC, Roe DJ, Stopeck A, Maskarinec G, Altbach M, Chalasani P, Huang C, Strom MB, Galons JP, Thompson PA. A randomized, placebo-controlled trial of diindolylmethane for breast cancer biomarker modulation in patients taking tamoxifen. Breast Cancer Res Treat. 2017 Aug;165(1):97-107. doi: 10.1007/s10549-017-4292-7. Epub 2017 May 30.

    PMID: 28560655DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

3,3'-diindolylmethane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cynthia Thomson

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 12, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2014

Study Completion

July 31, 2016

Last Updated

November 6, 2017

Record last verified: 2016-04

Locations

US(1)